NCT07036731Recruiting
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 428 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Bladder cancer
- NCT number
- NCT07036731
What you commit to
- Study type: Interventional
- Planned participants: 428
- From 1 Feb 2025 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second resection;
Other illness
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Any condition deemed by the investigator as potentially harming the subject or preventing the subject from meeting or fulfilling the study requirements;
Other
- Patients with incomplete pathological information of the sample;
- Patients with contaminated samples;
- Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
- Patients unable to provide written informed consent.
Who the study is looking for
- Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
- Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.), posing a risk of residual tumor;
- Absence of muscle layer tissue in the initial resection specimen;
- Post-initial resection pathology indicating T1 stage;
- Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
- Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
- Age ≥ 18 years;
- Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
- Willingness to sign the informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029 Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.